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510(k) K260108

L12 LED Light Source with AIM by Stryker Endoscopy — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2026
Date Received
January 14, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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